An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder Children
Attention Deficit Hyperactivity Disorder
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, OROS* Methylphenidate
Eligibility Criteria
Inclusion Criteria: Patients must be between 6 and 12 years of age inclusive, have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the DSM-IV established through clinical interview by the investigator and corroborated by the SNAP-IV parent rating scale, who in the opinion of the parents/caregivers exhibit significant after-school/evening behavioural difficulties where 12 hour coverage is desired Eligible patients will be evaluated after a minimum 3 day washout period without ADHD medication In addition, patients must also have a CGI-Severity score, at baseline of "moderate", "marked", "severe" or "extremely severe" in order to be eligible Patients could have had no prior treatment for ADHD or are presently taking something or could have had ADHD medication treatment in the past Exclusion Criteria: No patients with marked anxiety, tension, aggression or agitation, glaucoma, an ongoing seizure disorder, a psychotic disorder, a diagnosis of Tourette's disorder, or a family history of Tourette's disorder, bipolar disorder, suspected mental retardation, significant learning disability, eating disorder or history of one, pre-existing gastrointestinal narrowing No patient with inability to swallow the medication whole, those with any unstable medical illness were excluded